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Montelukast in Acute RSV Bronchiolitis

Primary Purpose

Bronchiolitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Montelukast
Placebo granules
Sponsored by
Ziv Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiolitis focused on measuring Bronchiolitis, controlled clinical trial, pediatrics, Infants, montelukast, Respiratory syncytial virus

Eligibility Criteria

4 Weeks - 2 Years (Child)All Sexes

Inclusion Criteria:

  • Age > 4 weeks < 2 years
  • Duration of respiratory symptoms < 4 days
  • Signs of bronchiolitis: prodromal rhinorrhea and cough, followed by at least two of the following signs: chest retractions, tachypnea, wheezing, or rales
  • First episode of wheezing or shortness of breath
  • Randomization within 12 hours of admission
  • No need for steroid treatment in the ward
  • Informed consent

Exclusion Criteria:

  • A history of asthma symptoms or any previous hospital admissions with respiratory tract illnesses and if they had ever been treated with anti-asthma medications (prior to the current illness).
  • Underlying cardiopulmonary disease such as bronchopulmonary dysplasia, congenital heart disease, immunodeficiency, or cystic fibrosis.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    1

    2

    Arm Description

    4mg Singulair© sachets

    Outcomes

    Primary Outcome Measures

    Length of stay

    Secondary Outcome Measures

    Full Information

    First Posted
    September 4, 2007
    Last Updated
    September 4, 2007
    Sponsor
    Ziv Hospital
    Collaborators
    Wolfson Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00524693
    Brief Title
    Montelukast in Acute RSV Bronchiolitis
    Official Title
    A Double-Blind Placebo Controlled Randomized Trial of Montelukast in Acute Respiratory Syncytial Virus Bronchiolitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2006 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Ziv Hospital
    Collaborators
    Wolfson Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    There is evidence of inflammatory mechanisms in RSV bronchiolitis with increased cysteinyl-leukotrienes (cys-LT). Recently, specific cys-LT receptor antagonists - montelukast (Singulair©) approved for use in infants as granule sachets, have become available. We evaluated the effect of Singulair© on clinical progress and on cytokine profiles in the acute phase of RSV bronchiolitis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bronchiolitis
    Keywords
    Bronchiolitis, controlled clinical trial, pediatrics, Infants, montelukast, Respiratory syncytial virus

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    51 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Active Comparator
    Arm Description
    4mg Singulair© sachets
    Arm Title
    2
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Montelukast
    Other Intervention Name(s)
    Singulair©
    Intervention Description
    4mg sachets
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo granules
    Primary Outcome Measure Information:
    Title
    Length of stay
    Time Frame
    hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Weeks
    Maximum Age & Unit of Time
    2 Years
    Eligibility Criteria
    Inclusion Criteria: Age > 4 weeks < 2 years Duration of respiratory symptoms < 4 days Signs of bronchiolitis: prodromal rhinorrhea and cough, followed by at least two of the following signs: chest retractions, tachypnea, wheezing, or rales First episode of wheezing or shortness of breath Randomization within 12 hours of admission No need for steroid treatment in the ward Informed consent Exclusion Criteria: A history of asthma symptoms or any previous hospital admissions with respiratory tract illnesses and if they had ever been treated with anti-asthma medications (prior to the current illness). Underlying cardiopulmonary disease such as bronchopulmonary dysplasia, congenital heart disease, immunodeficiency, or cystic fibrosis.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Israel Amirav, MD
    Organizational Affiliation
    Ziv Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18984650
    Citation
    Amirav I, Luder AS, Kruger N, Borovitch Y, Babai I, Miron D, Zuker M, Tal G, Mandelberg A. A double-blind, placebo-controlled, randomized trial of montelukast for acute bronchiolitis. Pediatrics. 2008 Dec;122(6):e1249-55. doi: 10.1542/peds.2008-1744. Epub 2008 Nov 4.
    Results Reference
    derived

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    Montelukast in Acute RSV Bronchiolitis

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